- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988585
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil (EPA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Cardiovascular Research Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy male or surgically sterile females between ages 21-70.
- BMI of 20-35.
Exclusion Criteria:
- competitive exerciser.
- current smokers.
- those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (> 500 mg/day) or vitamin E (> 400 units/day).
- those consuming more than 3 oily fish species/week.
- those consuming > 2 drinks/day.
- those with a history of a bleeding disorder, or history of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders such as uncontrolled thyroid disease, or uncontrolled hypertension or diabetes.
- those taking medications affecting serum lipids, body weight, or blood clotting.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Olive Oil
Olive Oil 600 mg/day
|
600 mg/day for 6 weeks
Other Names:
|
ACTIVE_COMPARATOR: EPA 1800
1800 mg/day
|
1800 mg/day for 6 weeks
Other Names:
|
ACTIVE_COMPARATOR: DHA
DHA 600 mg/day
|
600 mg/day for 6 weeks
Other Names:
|
ACTIVE_COMPARATOR: EPA 600
EPA 600 mg/day
|
EPA 600 mg/day for 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael L Dansiner, M.D., Cardiovascular Research Associates
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dupont-0609
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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